- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00623805
A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) as Maintenance Treatment in Patients With Metastatic Colorectal Cancer
2014년 7월 16일 업데이트: Hoffmann-La Roche
A Randomized, Multicenter Phase III Trial to Assess the Efficacy and Safety of Bevacizumab and Capecitabine as Maintenance Treatment, After Initial Combination Treatment With Capecitabine, Oxaliplatin and Bevacizumab in Patients With Metastatic Colorectal Adenocarcinoma
This 2 arm study assessed the efficacy and safety of maintenance treatment with Avastin (bevacizumab) + Xeloda (capecitabine), after initial treatment with Xeloda + oxaliplatin + Avastin, in patients with metastatic colorectal cancer.
Patients were randomized into one of 2 groups to receive 1) Xeloda + oxaliplatin + Avastin until disease progression or 2) Xeloda + oxaliplatin + Avastin for 6 3-week cycles, followed by Xeloda + Avastin until disease progression.
Xeloda was administered at a dose of 1000 mg/m^2 orally twice a day on days 1-14 of each cycle, oxaliplatin at a dose of 130 mg/m^2 intravenously (iv) on day 1 of each cycle, and Avastin at a dose of 7.5 mg/kg iv on day 1 of each cycle.
연구 개요
연구 유형
중재적
등록 (실제)
123
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ankara, 칠면조, 06100
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Ankara, 칠면조, 06500
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Ankara, 칠면조, 06590
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Gaziantep, 칠면조, 27310
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Istanbul, 칠면조, 34300
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Istanbul, 칠면조, 34390
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Istanbul, 칠면조, 34890
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Izmir, 칠면조, 35100
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Izmir, 칠면조, 35340
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S?hhiye, ANKARA, 칠면조, 06100
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Adult patients, ≥ 18 years of age.
- Histologically confirmed colon or rectal cancer, with unresectable metastatic disease.
- At least 1 measurable lesion.
- Outpatient, with Eastern Cooperative Oncology Group (ECOG) Performance Status = 0-1.
Exclusion Criteria:
- Previous treatment with Avastin.
- Previous systemic treatment for advanced or metastatic disease.
- clinically significant cardiovascular disease.
- Daily chronic treatment with high doses of aspirin (> 325 mg/day) or non-steroidal anti-inflammatory drugs.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Bevacizumab+capecitabine+oxaliplatin
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
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Bevacizumab was supplied as a solution in single-use vials.
다른 이름들:
카페시타빈은 필름 코팅된 정제로 공급되었습니다.
다른 이름들:
Oxaliplatin was supplied as a lyophilized powder in vials.
다른 이름들:
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실험적: Bevacizumab(B)+capecitabine(C)+oxaliplatin followed by B+C
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression.
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Bevacizumab was supplied as a solution in single-use vials.
다른 이름들:
카페시타빈은 필름 코팅된 정제로 공급되었습니다.
다른 이름들:
Oxaliplatin was supplied as a lyophilized powder in vials.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Progression-free Survival
기간: Baseline to the end of the study (up to 4 years, 2 months)
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Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first.
Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions.
All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline.
Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically).
A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
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Baseline to the end of the study (up to 4 years, 2 months)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Overall Survival
기간: Baseline to the end of the study (up to 4 years, 2 months)
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Overall survival was defined as the time from the first administration of study drug to death.
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Baseline to the end of the study (up to 4 years, 2 months)
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Percentage of Participants With a Complete Response or a Partial Response
기간: Baseline to the end of the study (up to 4 years, 2 months)
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A complete response was defined as the disappearance of all target lesions.
A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter.
All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline.
All other lesions (or sites of disease) should be identified as non-target lesions.
Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically).
A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
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Baseline to the end of the study (up to 4 years, 2 months)
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Time Until a Complete Response or a Partial Response
기간: Baseline to Month 13
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Time until a complete response or a partial response was defined as the time from the first administration of study drug until the first complete response or partial response.
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Baseline to Month 13
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Duration of Response
기간: Baseline to the end of the study (up to 4 years, 2 months)
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Duration of response was defined as the time from the first complete response or partial response until disease progression or death.
Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions.
All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline.
Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically).
A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
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Baseline to the end of the study (up to 4 years, 2 months)
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Percentage of Participants With Metastatic Lesions Previously Considered Inoperable Who Became Operable and Underwent Surgery
기간: Baseline to the end of the study (up to 4 years, 2 months)
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Baseline to the end of the study (up to 4 years, 2 months)
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Percentage of Participants With a R0 Resection
기간: Baseline to the end of the study (up to 4 years, 2 months)
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An R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.
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Baseline to the end of the study (up to 4 years, 2 months)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2008년 3월 1일
기본 완료 (실제)
2012년 5월 1일
연구 완료 (실제)
2012년 5월 1일
연구 등록 날짜
최초 제출
2008년 2월 18일
QC 기준을 충족하는 최초 제출
2008년 2월 18일
처음 게시됨 (추정)
2008년 2월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 8월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 7월 16일
마지막으로 확인됨
2014년 7월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen Breast Cancer...완전한
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Assiut University아직 모집하지 않음South Egypt Cancer Institute(SECI)에서 소아 악성종양 환자에 대한 KDIGO 기준을 사용하여 AKI의 누적 발병률을 확인하기 위해
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Bevacizumab에 대한 임상 시험
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University of Utah빼는
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National Center for Tumor Diseases, HeidelbergPfizer; Roche Pharma AG종료됨
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National Taiwan University Hospital종료됨